YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 320 drug applications between 4 April 2025 and 10 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 69 drug names.

2025/04/04 – 2025/04/10

Period
2025/04/04 to 2025/04/10, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
320
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
30

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

320filings, 96 of them generic

By application type

Application typeFilings
Supplement145
Generic96
New drug47
Import22
Unspecified5
Import re-registration5

By drug type

Drug typeFilings
Chemical drug214
TCM67
Therapeutic biologic36
Prophylactic biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets5360
2Dopamine Hydrochloride Injection423
3Brexpiprazole Tablets3131
4Oxacillin Sodium for Injection3113
5Rosuvastatin Calcium and Ezetimibe Tablets (I)225
6Ilaprazole Enteric-coated Tablets2226
7Iron Proteinsuccinylate Oral Solution2226
8Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)225
9Tadalafil Tablets2123
10Empagliflozin Tablets2118

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

196 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized11100
2Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized10100
3AstraZeneca AB630
4Bayer Inc.610
5Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
6Shandong Er Ye Pharmaceutical Co., Ltd. romanized540
7Boehringer Ingelheim International GmbH530
8Merck Healthcare KGaA530
9Shen Wei Pharma Group Co., Ltd. romanized430
10Takeda Pharmaceuticals U.S.A. Inc.420

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

101 this week

AcceptedDrugApplicants
2025/04/10Generic · Class 3 Bumetanide InjectionCYHS2501389 Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/04/10Generic · Class 3 Celecoxib TabletsCYHS2501388 Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized
2025/04/10Generic · Class 3 Minodronic acid TabletsCYHS2501386 Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501384 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2501383 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/04/10Generic · Class 3 Ferrous Succinate TabletsCYHS2501379 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2025/04/10New drug · Class 1.1 健脾解毒丸 · No verified English nameCXZL2500021 Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized
2025/04/10New drug · Class 1 LNF2102注射液 · No verified English nameCXSL2500287 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/04/10New drug · Class 1 SCG101-V自体T细胞注射液 · No verified English nameCXSL2500286 Xing Yuan De Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Xing Han De (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2025/04/10New drug · Class 1 注射用QLS32015 · No verified English nameCXSL2500285 Qilu Pharmaceutical Co., Ltd.
2025/04/10New drug · Class 2.2 QL2109注射液 · No verified English nameCXSL2500284 Qilu Pharmaceutical Co., Ltd.
2025/04/10New drug · Class 1.4 四价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2500283 Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized
2025/04/10New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500282 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2025/04/10New drug · Class 1 MSLN-CAR-T细胞注射液 · No verified English nameCXSL2500281 Shanghai Yi Hao Bio Technology Co., Ltd. romanized
2025/04/10New drug · Class 1 DZD6008片 · No verified English nameCXHL2500376 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/04/10New drug · Class 1 DZD6008片 · No verified English nameCXHL2500375 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/04/10New drug · Class 2.4 舒沃替尼片 · No verified English nameCXHL2500374 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/04/10New drug · Class 1 注射用TFX05-01 · No verified English nameCXHL2500373 Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized
2025/04/10New drug · Class 1 注射用SBK009 · No verified English nameCXHL2500372 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/10New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2500371 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/04/10New drug · Class 1 TQH3906胶囊 · No verified English nameCXHL2500370 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/04/10New drug · Class 1 VS-2218固体分散体片 · No verified English nameCXHL2500369 Wei Jiu Bio Technology (Suzhou) Co., Ltd. romanized
2025/04/10New drug · Class 1 VS-2218固体分散体片 · No verified English nameCXHL2500368 Wei Jiu Bio Technology (Suzhou) Co., Ltd. romanized
2025/04/09Import · Class 3.1 注射用阿帕达酶α · No verified English nameJXSS2500044 Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG
2025/04/09Import · Class 3.1 注射用阿帕达酶α · No verified English nameJXSS2500043 Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG
2025/04/09Import · Class 1 VAY736注射液 · No verified English nameJXSL2500057 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/04/09Import · Class 1 MEDI5752 · No verified English nameJXSL2500056 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/09Import · Class 1 ABBV-324注射用粉末 · No verified English nameJXSL2500055 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/04/09Import · Class 1 Casdatifan 片 · No verified English nameJXHL2500076 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2025/04/09Import · Class 1 BI1815368 片 · No verified English nameJXHL2500075 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd.

71 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.